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Office of Pediatric Therapeutics

 

 

Who We Are

The Office of Pediatric Therapeutics (OPT) is mandated by Congress. Its primary mission is to assure access for children to innovative, safe and effective medical products.  Historically, many medical products have not been tested for use in children. Pediatric product development studies require additional protection for children. Given its legislative mandate, OPT has developed four distinct yet interrelated programs to support FDA efforts to improve pediatric access.

What We Do

The OPT Scientific Activities Program works with FDA scientists and reviewers to assure that pediatric studies are rigorously designed and conducted in accord with current scientific understanding of such issues as exposure-response and extrapolation. OPT specifically reviews submitted pediatric data to develop “lessons learned” and to promote advancement of pediatric regulatory issues and science.

The OPT Ethics Program supports FDA efforts to assure that children are only enrolled in clinical studies which are both scientifically necessary and ethically appropriate.  Children should not become a mere commodity in the world market in response to FDA efforts to foster pediatric drug and biologic labeling.

The OPT Safety Program coordinates the mandated pediatric focused safety review by the Pediatric Advisory Committee for  drug and biologic products 18 months after labeling changes in response to voluntary and required pediatric studies.

The OPT International Program facilitates communication and collaboration between FDA and partner regulatory agencies around the world.  Pediatric clinical trials are necessarily global, given the incidence and distribution of diseases in the pediatric population, and thus FDA has a moral obligation to assure that children are not exposed to unnecessary, duplicative or poorly designed clinical trials world-wide.
 

Through these four distinct yet related programs, OPT works to assure timely access to medical products proven to be safe and effective for children.  OPT performs this core mission in a spirit of transparency, working closely with FDA partners to optimize the use of FDA advisory committees, communicate clearly the risks and benefits of FDA-regulated products marketed for children, and assess and publish FDA experience on which our regulatory decisions are based.
 

Office Organization
 

Office Pediatric Therapeutics
Director Office of Pediatric TherapeuticsMary Dianne Murphy, MD, FAAP
Deputy DirectorRobert "Skip" Nelson, MD, PhD, M.Div
Senior Policy AnalystTerrie Crescenzi, RPh
Management AnalystBrenda Harmon
Program Support SpecialistElizabeth Sanford
Pediatric Advisory Committee
Associate Director of Regulatory Affairs/Designated Official for Pediatric Advisory CommitteeWalter Ellenberg, PhD
Nurse Consultant Pediatric Advisory Committee COISheila Reese, BS, RN
Program Support Specialist Pediatric Adivsory Committee LogisticsEuneka Joseph, MBA
Ethics Program
Director of Ethics/Supervisory Medical OfficerRobert "Skip" Nelson, MD, PhD, M.Div
Pediatric Ethicist & Health AnalystMichelle Roth Cline, MD, PhD
Data AnalystCatherine Lee, DrPH
Special Medical Advisor Interggovernmental Personnel ActDaniel Fagbuyi, MD
Contractor (Data Entry)Kai Goodwin
Scientific Activities Program
Director of Science, Supervisory Medical OfficerWilliam Rodriguez, MD, PhD
Associate Director of Science and Director of KidNetAnn McMahon, MD, MS
Medical OfficerHaihao Sun, MD, PhD
Communications/Data SpecialistDeborah Avant, RPh
Economist/ Program AnalystGerold Wharton, MS
Intergovernmental Personnel Act: Duke UniversityKevin Watt
Safety Program
Director of Pediatric Safety/ Supervisory Medical OfficerJudith Cope, MD, MPH
Regulatory Health Project ManagerPam Weinel MS, MBA, RN
Regulatory Health Project ManagerAmy Odegaard, MPH
Medical Officer/EpidemiologistCongressional Mandate & Backfill Position
University of Maryland Nursing Fellow3 Month Assignment
International Program
Director of International Programs, Supervisory Medical OfficerJean Temeck, MD
Health Science AdministratorSuzanne Malli, BA, BSN
Health Science AdministratorRenan Bonnel, PharmD, MPH
Medical OfficerBackfill

 

Contact Us:

FDA/Office of the Commissioner

Office of Pediatric Therapeutics

White Oak Bldg.32

10903 New Hampshire Ave

Silver Spring, MD 20993-0002

Phone: 301- 796- 8659

Fax: 301-847- 8640 

 

Contact FDA

301-796-8659
OC-Office of Pediatric Therapeutics